Articulating Enseal Versus Ligasure Energy Devices

• Sponsor: University of Louisville (Other)
• Overall Status: Completed
• CT.gov ID: NCT02163538
• Collaborator: Ethicon Endo-Surgery (Industry)
• Enrollment: 142
• Locations: 2
• Arms: 2
• Duration (Months): 21
• Patients Per Site: 71
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

This is an exploratory study to assess the ability of the raw-TLX (raw Task Load Index) ergonomic assessment tool to detect differences in surgeon workload when using commercially available advanced bipolar devices. It is anticipated that the raw-TLX version of the validated NASA-TLX ergonomic assessment tool will detect less surgeon effort required in the procedure when articulating ENSEAL is utilized. The Articulating ENSEAL device may also positively impact other variables such as blood loss, operative time and cost.

Condition or Disease	Intervention/Treatment	Phase
Task Performance	Device: articulating Enseal; Device: Ligasure device	N/A

Detailed Description

This study is a single-center, single-blinded, randomized control, pilot trial that will be conducted at the University of Louisville Hospital. It is designed to assess whether there are different surgical outcomes with regard to surgeon perception of ease of instrument use, operative time, estimated blood loss, cost and perioperative complication rates between the Ethicon Articulating Enseal versus the LigaSure for total laparoscopic hysterectomy. This will be assessed using the raw-TLX version of the validated NASA-TLX scale.

The study will be single-blinded in that the patient will not be informed of their group assignment; it is impossible to blind the surgeon using the devices.

Methods and Procedures:

Patients undergoing total laparoscopic hysterectomy will be recruited from our University of Louisville Health Care Outpatient Center (HCOC) outpatient office and will be consented for participation in the study during their preoperative office visit.

Patients will be randomized pre-operatively on their date of surgery to one of two groups:

Group 1: The articulating Enseal device will be used during the hysterectomy. Group 2: The Ligasure device will be used during the hysterectomy.

All cases will be videotaped for review of operative time and complications; this is standard procedure at our institution.

To evaluate our primary objective, i.e., the potential ergonomic and surgical advantages of an articulating tip in an energy device, the raw-TLX of the validated NASA-TLX scale will be completed by the primary surgeon at the end of each surgery.

Subjects will be seen for study follow-up during their routine post-operative visits at 2 weeks, 6 weeks and within 3 months after surgery in the event of a hospital admission for a surgery-related complication.

No compensation for participation will be offered to patients and no compensation for subject recruitment will be gained by investigators. This will be disclosed during the informed consent process.

Inclusion Criteria:

• Age 18 or older

• Able and willing to provide informed consent

• Undergoing total laparoscopic hysterectomy

Exclusion Criteria:

• Under 18 years of age

• Severe endometriosis or adhesions requiring >15min of adhesiolysis prior to beginning hysterectomy

• Unsafe to use energy device due to decreased visualization or any other reason deemed to be unsafe by the surgeon

• Intra-operative decision to convert to laparotomy prior to use of energy device

• Current diagnosis of uterine, tubal ovarian or cervical malignancy.

• Patients who cannot read/understand English.

Study Design

• Study Type: Interventional
• Actual Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: A Comparison of Industry Leading Energy Devices for Use in Gynecologic Laparoscopy: Articulating Enseal Versus Ligasure Energy Devices
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: articulating Enseal This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.	Device: articulating Enseal; Vessel-sealing device used for laparoscopic hysterectomy.
Active Comparator: Ligasure device This group of women undergoing hysterectomy is randomized to the Ligasure energy device.	Device: Ligasure device; Vessel-sealing device used for laparoscopic hysterectomy.

Outcome Measures

Primary Outcome Measures

1. Raw Task Load Index (TLX) Score Assigned by Surgeons [18 months]

   The Official NASA Task Load Index (TLX) is a subjective workload assessment tool to allow users to perform subjective workload assessments on operator(s) working with various human-machine interface systems. By incorporating a multi-dimensional rating procedure, NASA TLX derives an overall workload score based on a weighted average of ratings on six subscales given below. The overall workload score ranges between 0 and 100 with 100 being the most demanding. Mental Demand Physical Demand Temporal Demand Performance Effort Frustration

Secondary Outcome Measures

1. Intra- and Post-operative Complications [18 months]

2. Estimated Blood Loss [18 months]

3. Need for Second Energy Device Intra-operatively [18 months]

4. Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis. [During procedure]

5. Time Required to Complete Procedure [End of surgery up to 4 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 18 or older

• Able and willing to provide informed consent

• Undergoing total laparoscopic hysterectomy

Exclusion Criteria:

• Under 18 years of age

• Severe endometriosis or adhesions requiring >15min of adhesiolysis prior to beginning hysterectomy

• Unsafe to use energy device due to decreased visualization or any other reason deemed to be unsafe by the surgeon intra-operative decision to convert to laparotomy prior to use of energy device

• Current diagnosis of uterine, tubal ovarian or cervical malignancy.

• Patients who cannot read/understand English.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville Health Care Outpatient Center	Louisville	Kentucky	United States	40202
2	University of Louisville Hospital	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• University of Louisville
• Ethicon Endo-Surgery

Investigators

• Principal Investigator: Resad Pasic, MD, PhD, University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Resad Pasic, Professor with Tenure of Obstetrics and Gynecology, University of Louisville
• ClinicalTrials.gov Identifier: NCT02163538
• Other Study ID Numbers: Energy Devices-UL
• First Posted: Jun 13, 2014
• Last Update Posted: Feb 13, 2018
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Resad Pasic, Professor with Tenure of Obstetrics and Gynecology, University of Louisville: energy device; laparoscopic; hysterectomy; enseal; ligasure; raw tlx

Study Results

Participant Flow

Arm/Group Title	Articulating Enseal	Ligasure Device
Arm/Group Description	This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device. articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.	This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Period Title: Overall Study
STARTED	71	71
COMPLETED	70	70
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Articulating Enseal	Ligasure Device	Total
Arm/Group Description	This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device. articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.	This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.	Total of all reporting groups
Overall Participants	70	70	140
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.6 (6.9)	41.3 (7.7)	41.4 (7.2)
Sex: Female, Male (Count of Participants)
Female	70 100%	70 100%	140 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	70 100%	70 100%	140 100%

Outcome Measures

1. Primary Outcome

Title	Raw Task Load Index (TLX) Score Assigned by Surgeons
Description	The Official NASA Task Load Index (TLX) is a subjective workload assessment tool to allow users to perform subjective workload assessments on operator(s) working with various human-machine interface systems. By incorporating a multi-dimensional rating procedure, NASA TLX derives an overall workload score based on a weighted average of ratings on six subscales given below. The overall workload score ranges between 0 and 100 with 100 being the most demanding. Mental Demand Physical Demand Temporal Demand Performance Effort Frustration
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Articulating Enseal	Ligasure Device
Arm/Group Description	This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device. articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.	This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Measure Participants	70	70
Median (Inter-Quartile Range) [units on a scale]	51.7	32.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Articulating Enseal, Ligasure Device
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Intra- and Post-operative Complications
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Articulating Enseal	Ligasure Device
Arm/Group Description	This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device. articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.	This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Measure Participants	70	70
Count of Participants [Participants]	1 1.4%	2 2.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Articulating Enseal, Ligasure Device
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Estimated Blood Loss
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Articulating Enseal	Ligasure Device
Arm/Group Description	This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device. articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.	This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Measure Participants	70	70
Median (Inter-Quartile Range) [mL]	100	100

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Articulating Enseal, Ligasure Device
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.582
	Comments
	Method	Chi-squared
	Comments

4. Secondary Outcome

Title	Need for Second Energy Device Intra-operatively
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Articulating Enseal	Ligasure Device
Arm/Group Description	This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device. articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.	This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Measure Participants	70	70
Count of Participants [Participants]	10 14.3%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Articulating Enseal, Ligasure Device
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0031
	Comments
	Method	Chi-squared
	Comments

5. Secondary Outcome

Title	Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Articulating Enseal	Ligasure Device
Arm/Group Description	This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device. articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.	This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Measure Participants	70	70
Median (Inter-Quartile Range) [minutes]	35	30

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Articulating Enseal, Ligasure Device
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0281
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Time Required to Complete Procedure
Time Frame	End of surgery up to 4 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Articulating Enseal	Ligasure Device
Arm/Group Description	This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device. articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.	This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Measure Participants	70	70
Median (Inter-Quartile Range) [Minutes]	97	85

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Articulating Enseal, Ligasure Device
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.0821
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	Articulating Enseal		Ligasure Device
Arm/Group Description	This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device. articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.		This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
All Cause Mortality
	Articulating Enseal		Ligasure Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/70 (0%)
Serious Adverse Events
	Articulating Enseal		Ligasure Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/70 (2.9%)		1/70 (1.4%)
Blood and lymphatic system disorders
blood transfusion	1/70 (1.4%)	1	1/70 (1.4%)	1
Injury, poisoning and procedural complications
rectal injury	1/70 (1.4%)	1	0/70 (0%)	0
Other (Not Including Serious) Adverse Events
	Articulating Enseal		Ligasure Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/70 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.